[Federal Register Volume 63, Number 168 (Monday, August 31, 1998)]
[Notices]
[Pages 46227-46228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23271]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0646]


Global Harmonization Task Force: Draft Documents on Adverse Event 
and Vigilance Reporting of Medical Device Events; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of five draft documents entitled ``Comparison of Device 
Adverse Report Systems'' (SG2-N6), ``Guidance on How to Handle 
Information Concerning Vigilance Reporting Related to Medical Devices'' 
(SG2-N8), ``Global Medical Devices Vigilance Report (Form and 
Instructions)'' (SG2-N9), ``Pre' cis'' (Vigilance and Postmarket 
Surveillance) (SG2-N12), and ``Adverse Event Reporting Guidelines for 
Manufacturers'' (SG-N21). These documents have been prepared by members 
of the Global Harmonization Task Force (GHTF), study group 2 on Medical 
Devices Vigilance/Postmarket Surveillance Reporting Systems. The 
documents are intended to provide information only and represent a 
harmonized group of proposals. Elements of the approach set forth in 
these documents may not be consistent with current U.S. regulatory 
requirements. FDA is requesting comments on these documents.

DATES: Written comments by September 30, 1998. After the close of the 
comment period, written comments may be submitted at any time to Larry 
G. Kessler (address below).

ADDRESSES: Submit written comments on the draft documents to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be 
identified with the docket number found in brackets in the heading of 
this document. If you do not have access to the World Wide Web (WWW), 
submit written requests for single copies on a 3.5'' diskette of the 
draft documents entitled ``Draft Documents on Adverse Event and 
Vigilance Reporting of Medical Device

[[Page 46228]]

Events'' to the Division of Small Manufacturers Assistance (HFZ-220), 
Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist that office in processing your 
requests, or fax your request to 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to these draft 
documents.

FOR FURTHER INFORMATION CONTACT: Larry G. Kessler, Office of 
Surveillance and Biometrics (HFZ-500), Center for Devices and 
Radiological Health, Food and Drug Administration, 9200 Corporate 
Blvd., Rockville, MD 20850, 301-594-2812.

SUPPLEMENTARY INFORMATION:

 I. Background

    FDA has participated in a number of activities to promote the 
international harmonization of regulatory requirements, as described in 
an FDA notice on these activities published in the Federal Register of 
October 11, 1995 (60 FR 53078). As part of this effort, FDA has been 
actively involved since 1992 with GHTF. GHTF has formed four study 
groups, each tasked with assignments to draft documents and carry on 
other activities, designed to facilitate global harmonization. The 
purpose of this notice is to seek public comments on draft documents 
that have been prepared by one of the GHTF study groups.
    Study group 2 was formed by GHTF in February 1996 and tasked with 
the responsibility to examine the requirements for the reporting of 
adverse incidents involving medical devices; consider postmarket 
surveillance and other forms of vigilance; and recommend ways of 
harmonizing these requirements. Study group 2 was also requested to 
promote the dissemination of relevant information concerning these 
matters. Study group 2 helps to improve protection of the health and 
safety to patients, users, and others; evaluate reports and disseminate 
information which may reduce the likelihood of or prevent repetitions 
of adverse events, or alleviate consequences of such repetitions; and 
define postmarket medical device reporting and surveillance 
requirements and guidelines on an international basis.
    Reporting of adverse events involving medical devices is an 
important element in any good postmarketing surveillance system and can 
be achieved only through mutual confidence among all parties concerned. 
The obligation to report adverse events differs widely among countries. 
Some systems are voluntary, while others are mandatory. The common 
thread that could tie all of the worldwide reporting systems together 
is the obligation for the manufacturer to report adverse events or 
incidents of which they are aware that involve medical devices.
    It is the premise of the work of GHTF study group 2 that an 
international system for reporting adverse events can be developed to 
handle information provided by the manufacturer to the authorities.
    1. In the draft document entitled ``Comparison of the Device 
Adverse Report Systems'' (SG2-N6), study group 2 compares 11 aspects of 
the regulatory systems of each of these countries with respect to the 
purpose of the device adverse event report systems, applicability, 
report timing, reporting criteria, not reportable incidents/events, 
procedures to report, applicable forms, content of the forms, role of 
the authority, definitions, and responsible entity for the 
investigation of the adverse event.
    2. In the draft document entitled ``Guidance on How to Handle 
Information Concerning Vigilance Reporting Related to Medical Devices'' 
(SG2-N8), information and guidance is provided that represents a 
harmonized proposal. This document contains information on 
communication between National Competent Authorities on events related 
to medical devices; when and how to inform publicly about adverse 
events; concerns with releasing information nationally; a list of 
criteria on how to disseminate information on adverse events, 
nationally; and recommendations on when an authority decides to 
disseminate information to the public.
    3. In the draft document entitled ``Global Medical Devices 
Vigilance Report (Form and Instructions)'' (SG2-N9), information and 
guidance is provided about relevant measurers and/or recommendations 
relating to the prevention of adverse incidents concerning medical 
devices.
    4. In the draft document entitled ``Pre'cis'' (SG2-N12R6), an 
overview and focus is provided of the mission, scope, and activities of 
the GHTF-SG-2.
    5. In the draft document entitled ``Adverse Event Reporting 
Guideline for Decisions for Manufacturers'' (SG2-N21), a ``Decision 
Tree'' matrix is presented for manufacturers and their representatives 
to decide when an adverse event should be reported.
    It should be noted that these GHTF draft documents represent the 
current thinking and directions for harmonized postmarket surveillance, 
adverse event, and vigilance reporting aspects worldwide. These draft 
documents are presented for review and comment so that industry and 
other members of the public may express their views regarding global 
harmonization of medical device adverse event reporting.

 II. Electronic Access

    Persons interested in obtaining a copy of these draft documents may 
also do so using the WWW. CDRH maintains an entry on the WWW for easy 
access to the Web. Updated on a regular basis, the CDRH Home Page 
includes ``Draft Documents on Adverse Event and Vigilance Reporting of 
Medical Device Events,'' device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video-oriented conferencing 
and electronic submissions, mammography matters, and other device 
oriented information. The CDRH home page may be accessed at http://
www.fda.gov/cdrh.

 III. Comments

    Interested persons may on or before September 30, 1998, submit to 
the Dockets Management Branch (address above) written comments 
regarding the draft documents. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document and with the full title of these documents. The draft 
documents and received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.
    After September 30, 1998, written comments regarding the draft 
documents may be submitted at any time to the contact person (address 
above).

    Dated: August 19, 1998.
 D.B. Burlington,
 Director, Center for Devices and Radiological Health.
[FR Doc. 98-23271 Filed 8-28-98; 8:45 am]
BILLING CODE 4160-01-F